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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN24979756 |
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Date of registration:
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19/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of a group training for adolescents (emotion regulation training) with emotion regulation problems
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Scientific title:
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Date of first enrolment:
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01/06/2005 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN24979756 |
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Study type:
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Interventional |
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Study design:
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Multicentre randomised single-blind active-controlled parallel-group trial (Quality of life)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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H.M.
Schuppert |
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Address:
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University Medical Center Groningen
Department of Psychiatry
P.O. Box 30001
9700 AR
Groningen
Netherlands |
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Telephone:
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Email:
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m.schuppert@accare.nl |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age 14 - 18 years
2. Emotion regulation problems
3. Some self-awareness
4. Sufficient internal motivation
5. Willing to share his or her experiences in a group
6. Environment is rather stable
7. Capable to join a group-session without aggressive behaviour
8. No substance abuse and self-mutilating behaviour during the session
Exclusion criteria: If the adolescent does not meet the inclusion criteria.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psychiatric, mental disorders/illness, borderline personality disorder
Mental and Behavioural Disorders
Specific personality disorders
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Intervention(s)
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The emotion regulation training (ERT) is a skills training (17 weekly sessions of 1.75 hours as well as one session for significant others) based on psycho-education, cognitive behavioural principles, and exercises for relaxation.
Care as usual generally includes individual sessions with the adolescent and medication checks, sometimes combined with family sessions, crisis intervention or parent training.
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Primary Outcome(s)
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1. Borderline Personality Disorder Severity Index (BPDSI and BPDSI - parent version): a semi-structured interview based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) classification of psychopathology. Trained psychologists will conduct this semi-structured interview.
2. VERS-scale: to measure negative as well as positive behaviour in a certain period. This questionnaire is to be completed by the adolescent as well as the parents.
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Secondary Outcome(s)
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Questionnaires completed by the adolescents as well as the parents:
1. Frequency list of Emotion Regulation Problems (F-ERP)
2. Global Assessment of Functioning (GAF): present level of functioning (axis V of DSM-IV)
3. MALC-ERT: list of 18 items to draw up an inventory of cognitions on emotional dysregulation (locus of control)
4. Child Behaviour Checklist (CBCL): consists of 118 items describing a wide domain of behaviour problems of children
Questionnaire only to be completed by parents:
Nijmeegse Ouderlijke Stress Index (NOSI; Parental Stress Index): to measure stress in parents (124 items)
Questionnaire only to be completed by the adolescent:
Healthcare consumption: a short list to be completed weekly during the training, about different types of healthcare being used in the last week (e.g. primary healthcare, emergency rooms, crisis contact psychiatry department).
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Secondary ID(s)
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1558; NTR356
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Source(s) of Monetary Support
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Not provided at time of registration
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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